지침,참고문헌 | MDCG 2019-10 Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC

mdcg_2019_10_application_transitional_provisions_certificates.pdf (69.1K) [32]

Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC
According to Article 120(2) of Regulation (EU) 2017/475 on Medical Devices (the MDR), certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC (the Directives) will remain valid until 27 May 2024 at the latest. However, Article 120(3) establishes specific conditions that such certificates, and the related devices thereof, have to comply with. In particular, it is required that the notified body that issued the certificate
– under a valid designation
– continues to be responsible for the appropriate surveillance activities with respect to all of the applicable requirements related to the devices it has certified and that it has the possibility to take any necessary measure in relation to those.
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